283P - Patient profiles treated with extended adjuvant neratinib in the early access registry study: NEAR study

Background

Neratinib is an oral pan-HER TKI approved in 2018 in Europe in adult patients with HR+ HER2+ early breast cancer (eBC) who completed adjuvant trastuzumab-based therapy. The approval is based on the phase III ExteNET trial that demonstrated clinically meaningful benefit for neratinib vs. placebo in this population, including significantly improved 5-year iDFS (Δ5.1%, HR 0.58, 95% CI 0.41-0.82). An Early Access Program (EAP) was initiated in Europe in 2017 and provided access to individual patients for extended adjuvant neratinib based upon the ExteNET protocol while neratinib was awaiting product approval and availability in multiple countries. Since ExteNET, the treatment landscape of HER2+ eBC has evolved and there is a need to document the clinical profile, the tolerability, and the effectiveness of patients treated with neratinib in a real-world setting.

Methods

This is a multicenter, retrospective, observational, longitudinal study in Croatia, France, Belgium, Spain and Italy. Eligible patients will be selected among those having received at least one dose of neratinib in the EAP, between 01/08/17 and 31/12/20. The aim of the study is to describe the characteristics of patients receiving neratinib and its use in the real world. Demography and clinical profiles of patients are presented.

Results

As of 30/01/23, 108 patients were included in the Full Analysis Set. Median age at neratinib initiation was 48.0 years and 37.4% of patients were premenopausal. 29.6% of patients had cT1 and 46.3% had cT2. Two-thirds of patients were N+ and three-quarters had stage II + III tumours. Overall, 85.2% of patients had HR+ eBC. 41.7% of patients had upfront surgery followed by adjuvant therapy while 58.3% received neoadjuvant therapy first; of them 19.0% achieved a pathological complete response. In the neoadjuvant setting, most patients received trastuzumab + pertuzumab (58.7%) and trastuzumab (31.7%), whereas in the adjuvant setting, anti-HER2 treatment mainly consisted of trastuzumab (79.6%).

Conclusions

Patients treated in this EAP reflected the profile of patients who were expected to receive extended adjuvant neratinib during the observational period, which included the use of more recent (neo)adjuvant treatments.

Clinical trial identification

NCT05599334.

Editorial acknowledgement

Legal entity responsible for the study

Pierre Fabre.

Funding

Pierre Fabre.

Disclosure

M. De Laurentiis: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, Novartis, Seagen, Eli Lilly, Takeda, Daiichi Sankyo, Tomalab, Gilead, Genetic, Menarini, Sophos; Financial Interests, Personal, Sponsor/Funding: Roche, AstraZeneca; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Seagen, Roche, Ipsen, Pfizer, AstraZeneca, Sanofi, Pierre Fabre, Daiichi Sankyo, GSK. X. González Farre: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Pierre Fabre, Novartis, Roche; Financial Interests, Personal, Sponsor/Funding: AstraZeneca, Roche, Lilly. O. Romano: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, Amgen, Pfizer. A. Cano Jimenez: Financial Interests, Personal, Speaker, Consultant, Advisor: Pierre Fabre, Pfizer. F. Beghdad, O. Dialla, M. Zivanov: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre. T. Silovski: Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis, Pfizer, Eli Lilly, Roche, Amgen, Sandoz, Abbott, AstraZeneca; Financial Interests, Personal, Sponsor/Funding: Pfizer, Novartis, Roche; Financial Interests, Institutional, Product Samples: Novartis, Pfizer, Puma Biotechnology Inc. All other authors have declared no conflicts of interest.